Robert Dostert, DNV

Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?

By Robert Dostert

…Health (europa.eu) as well as Team-NB. These are invaluable resources for industry to understand the application of MDR in their technical documentation and quality management systems. Content Sponsored by DNV….

…Health (europa.eu) as well as Team-NB. These are invaluable resources for industry to understand the application of MDR in their technical documentation and quality management systems. Content Sponsored by DNV….

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James Thompson, Siemens

Ask the Expert: Leveraging the Digital Infrastructure to Align with Best Practices and Accelerate Growth

By MedTech Intelligence Staff

…life-saving products to patients who need them. MedTech Intelligence: What is the Siemens answer to the FDA – Case for Quality program and the new EU MDR requirements? Thompson: Siemens…

…life-saving products to patients who need them. MedTech Intelligence: What is the Siemens answer to the FDA – Case for Quality program and the new EU MDR requirements? Thompson: Siemens…

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Geoff Wood, DNV

Ask the Expert: What Advantages Does a Pre-Assessment Offer?

…(i.e. ISO 13485:2016, MDR, or MDSAP) and are new to MD manufacturing, benefit greatly. Typically, these manufacturers are established in other markets such as aerospace, semiconductor, or automotive and already…

…(i.e. ISO 13485:2016, MDR, or MDSAP) and are new to MD manufacturing, benefit greatly. Typically, these manufacturers are established in other markets such as aerospace, semiconductor, or automotive and already…

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Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne

Manufacturers around the world are preparing for the upcoming implementation of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulations. For medical device and diagnostics…

Manufacturers around the world are preparing for the upcoming implementation of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulations. For medical device and diagnostics…

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European Union Flag

Corrections, Corrective Actions, and Preventive Actions: Effectively Handling Nonconformances in Compliance with the EU MDR

By Bryan Brosseau

…a form of correction with respect to your quality management system, not corrective action as defined in the EU MDR (The definition of ‘corrective action’ in the EU MDR (2017/745)…

…a form of correction with respect to your quality management system, not corrective action as defined in the EU MDR (The definition of ‘corrective action’ in the EU MDR (2017/745)…

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MedTech Intelligence

Top MedTech Summer Stories

By MedTech Intelligence Staff

…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…

…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…

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Bryan Brosseau, Brosseau Consulting

EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation

By Bryan Brosseau

…in some organizations already coincide with the requirements in the new EU Medical Devices Regulation (EU Regulation 2017/745). The new requirements in the EU MDR do not add significant burden…

…in some organizations already coincide with the requirements in the new EU Medical Devices Regulation (EU Regulation 2017/745). The new requirements in the EU MDR do not add significant burden…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

One and Done: It Happens!

By Dr. Christopher Joseph Devine

…certain product failures are automatic MDRs Record keeping for all MDRs (recommend using a different color folder for MDRs versus routine product complaints) Investigative steps to be taken when suspect…

…certain product failures are automatic MDRs Record keeping for all MDRs (recommend using a different color folder for MDRs versus routine product complaints) Investigative steps to be taken when suspect…

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Peter Rose, Maetrics
Soapbox

New MDR: One Year into the Transition Period

By Peter Rose

…Device Regulation (MDR); in May last year, the Official Journal of the European Union announced the start of the MDR implementation process, confirming 2020 as the year when it will…

…Device Regulation (MDR); in May last year, the Official Journal of the European Union announced the start of the MDR implementation process, confirming 2020 as the year when it will…

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